A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer
This study has two purposes:
- To determine what different strengths and number of doses of EGEN-001, administered
directly into the peritoneal cavity, can be given safely in combination with standard
intravenous chemotherapy for ovarian cancer
- To evaluate the anti-cancer activity of EGEN-001 when combined with standard
chemotherapy; biological markers of EGEN-001 activity will be collected and ovarian
cancer burden will be evaluated per standard practice.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer.
12-14 months
Yes
Ronald D. Alvarez, MD
Principal Investigator
Division of Gynecologic Oncology at University of Alabama at Birmingham
United States: Food and Drug Administration
EGEN-001-201
NCT00473954
April 2007
November 2009
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Oncology Specialties, PC | Huntsville, Alabama 35805 |